Notice2022-08303
Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act; Draft Guidance for FDA Staff and Stakeholders; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
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Published
April 19, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for FDA staff and stakeholders entitled "Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act." This draft guidance, when finalized, will explain our current thinking on the approach we generally intend to take when we evaluate the public health importance of a food allergen other than milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybean, and sesame (non-listed food allergen). (In April 2021, the Food Allergy Safety, Treatment, Education, and Research Act of 2021 amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to add sesame to the definition of "major food allergen." This statutory requirement goes into effect on January 1, 2023). We are also announcing an opportunity for public comment on our proposed collection of information. This draft guidance is not final nor is it in effect at this time.
Full Text
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<title>Federal Register, Volume 87 Issue 75 (Tuesday, April 19, 2022)</title>
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[Federal Register Volume 87, Number 75 (Tuesday, April 19, 2022)]
[Notices]
[Pages 23181-23184]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08303]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0553]
Evaluating the Public Health Importance of Food Allergens Other
Than the Major Food Allergens Listed in the Federal Food, Drug, and
Cosmetic Act; Draft Guidance for FDA Staff and Stakeholders;
Availability; Agency Information Collection Activities; Proposed
Collection; Comment Request
AGENCY: Food and Drug Administration, HHS.
[[Page 23182]]
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for FDA staff and stakeholders
entitled ``Evaluating the Public Health Importance of Food Allergens
Other Than the Major Food Allergens Listed in the Federal Food, Drug,
and Cosmetic Act.'' This draft guidance, when finalized, will explain
our current thinking on the approach we generally intend to take when
we evaluate the public health importance of a food allergen other than
milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts,
soybean, and sesame (non-listed food allergen). (In April 2021, the
Food Allergy Safety, Treatment, Education, and Research Act of 2021
amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to add
sesame to the definition of ``major food allergen.'' This statutory
requirement goes into effect on January 1, 2023). We are also
announcing an opportunity for public comment on our proposed collection
of information. This draft guidance is not final nor is it in effect at
this time.
DATES: Submit either electronic or written comments on the draft
guidance by August 17, 2022 to ensure that we consider your comment on
this draft guidance before we begin work on the final version of the
guidance. Submit electronic or written comments on the proposed
collection of information in the draft guidance by August 17, 2022.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2021-N-0553 for ``Evaluating the Public Health Importance of Food
Allergens Other Than the Major Food Allergens Listed in the Federal
Food, Drug, and Cosmetic Act.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Compliance Policy Staff, Office of Compliance (HFS-605), Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740. Send two self-addressed adhesive
labels to assist that office in processing your requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
With regard to the draft guidance: Stefano Luccioli, Office of
Compliance (HFS-605), Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740,
240-402-1283, <a href="/cdn-cgi/l/email-protection#c98a8f9a88878aa6a4b9a5a0a8a7aaacb9a6a5a0aab089afada8e7a1a1bae7aea6bf"><span class="__cf_email__" data-cfemail="45060316040b062a2835292c242b2620352a292c263c052321246b2d2d366b222a33">[email protected]</span></a>; or Alexandra Jurewitz,
Office of Regulations and Policy (HFS-024), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-2378.
With regard to the proposed collection of information: Domini Bean,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
5733, <a href="/cdn-cgi/l/email-protection#c8989a899bbca9aeae88aeaca9e6a0a0bbe6afa7be"><span class="__cf_email__" data-cfemail="b9e9ebf8eacdd8dfdff9dfddd897d1d1ca97ded6cf">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Food allergy can be broadly defined as an adverse health effect
arising from a specific immune response that occurs reproducibly on
exposure to a given food. A food allergen is the food or component(s)
(often a protein) of a food that elicits specific immunologic
reactions. While many different types of food allergies have been
identified, food allergies that are most studied and understood
clinically are those due to immunoglobulin E antibodies (IgE) that
cause the body to release inflammatory chemicals. The most severe and
immediately life-threatening food allergies are those that are mediated
by
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IgE and are capable of triggering anaphylaxis, which can be fatal. The
focus of the draft guidance is IgE-mediated food allergy.
In general, the regulatory framework of the FD&C Act and our
regulations implementing the FD&C Act broadly apply to the production
of food that is or contains a food allergen through statutory and
regulatory provisions regarding: (1) Food labeling; (2) food production
(e.g., manufacturing, processing, packing, and holding food); and (3)
the safety of substances added to food. The Food Allergen Labeling and
Consumer Protection Act of 2004 amended the FD&C Act to provide us with
additional, specific authority regarding the labeling of a food (other
than a raw agricultural commodity) that bears or contains a ``major
food allergen.'' Under section 403(w) of the FD&C Act (21 U.S.C.
343(w)), a food is misbranded if it contains a major food allergen and
fails to declare that major food allergen as specified on its label
using the major food allergen's common or usual name. Section
201(qq)(1) of the FD&C Act (21 U.S.C. 321(qq)(1)) defines a ``major
food allergen,'' in part, as any of the following: Milk, eggs, fish
(e.g., bass, flounder, or cod), Crustacean shellfish, tree nuts (e.g.,
almonds, pecans, or walnuts), wheat, peanuts, and soybean. In April
2021, the Food Allergy Safety, Treatment, Education, and Research Act
of 2021 amended section 201(qq) of the FD&C Act to add sesame to the
definition of ``major food allergen.'' This amendment applies to ``any
food that is introduced or delivered for introduction into interstate
commerce on or after January 1, 2023'' (Pub. L. 117-11).
We are announcing the availability of a draft guidance for FDA
staff and stakeholders entitled ``Evaluating the Public Health
Importance of Food Allergens Other Than the Major Food Allergens Listed
in the Federal Food, Drug, and Cosmetic Act.'' We are issuing the draft
guidance consistent with our good guidance practices regulation (21 CFR
10.115). The draft guidance, when finalized, will represent the current
thinking of FDA on this topic. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
The draft guidance discusses: (1) The scientific factors that we
would generally intend to consider when evaluating the public health
importance of a non-listed food allergen; (2) other information,
relevant to the labeling and production of food containing the food
allergen, that we would generally intend to consider when evaluating
the public health importance of a non-listed food allergen; and (3) our
tentative recommendations for how to identify and evaluate the body of
evidence applicable to an evaluation of the public health importance of
a non-listed food allergen.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501-3521),
Federal Agencies must obtain approval from the Office of Management and
Budget (OMB) for each collection of information they conduct or
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3)
and 5 CFR 1320.3(c) and includes Agency requests or requirements that
members of the public submit reports, keep records, or provide
information to a third party. Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day
notice in the Federal Register concerning each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing notice of the proposed
collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Evaluating the Public Health Importance of Food Allergens Other Than
the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic
Act
OMB Control Number 0910-0191--Revision
The draft guidance, when finalized, will describe our current
thinking on the approach we generally intend to take when we evaluate
the public health importance of a non-listed food allergen. Respondents
who are interested in asking FDA to evaluate a food or component of
food as a food allergen of public health importance may submit
information relevant to their request in accordance with Sec. 10.30
(21 CFR 10.30). We recommend that the submitted information include
data demonstrating that the food allergy is IgE-mediated and data for
prevalence, severity, and potency, as described in the draft guidance.
Description of respondents: The respondents to this collection of
information are any persons who file citizen petitions under 21 CFR
10.30, which may include manufacturers and packers of packaged foods
sold in the United States that may contain a non-listed food allergen
and individuals and organizations interested in evaluating a food or
component of food as a food allergen of public health importance.
Respondents are from the private sector (for-profit businesses and non-
profit entities).
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity; 21 CFR section Number of responses per Total annual Avg. burden per Total hours
respondents respondent responses response
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Submitting data for evidence of IgE-mediated food allergy, 1 1 1 80 80
prevalence, severity, and potency; 10.30..........................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We base these estimates on our experience with reviewing and
evaluating data for food allergens. We estimate that one respondent
will spend approximately 80 hours developing and
[[Page 23184]]
submitting the information to FDA each year.
This draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in 21 CFR part 10 have been approved under OMB control number 0910-
0191. The collections of information in 21 CFR part 101 have been
approved under OMB control number 0910-0381. The collections of
information in section 403(w) of the FD&C Act have been approved under
OMB control number 0910-0792. The collections of information in 21 CFR
part 117 have been approved under OMB control number 0910-0751. The
collections of information for Form FDA 3800 have been approved under
OMB control number 0910-0645. The collections of information for Form
FDA 3500 have been approved under OMB control number 0910-0291. The
collections of information in 21 CFR 70.25, 71.1, 170.36, 171.1, 172,
173, 179, and 180 have been approved under OMB control number 0910-
0016.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either <a href="https://www.fda.gov/FoodGuidances">https://www.fda.gov/FoodGuidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.
Dated: April 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08303 Filed 4-18-22; 8:45 am]
BILLING CODE 4164-01-P
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